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A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77)

Primary Purpose

Metastatic Non-small Cell Lung Cancer

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pembrolizumab coformulated with hyaluronidase
Pemetrexed
Cisplatin
Carboplatin
Paclitaxel
Nab-paclitaxel
Pembrolizumab
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

The key inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: Has histologically or cytologically confirmed diagnosis of squamous or non-squamous Non-small Cell Lung Cancer (NSCLC). Must provide archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated. Has a life expectancy of at least 3 months. Exclusion Criteria: Has a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements. Has received prior systemic anticancer therapy for metastatic NSCLC. Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization. Has received prior radiotherapy within 2 weeks of start of study intervention or has radiation-related toxicity requiring corticosteroids. Has received radiation therapy to the lung (>30 Gray) within 6 months of start of study intervention. Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Has an active autoimmune disease that has required systemic treatment in past 2 years. Has an active infection requiring systemic therapy. Has a history of human immunodeficiency virus (HIV) infection. Has a history of Hepatitis B or C. Has not adequately recovered from major surgery or has ongoing surgical complications. Has a history of allogenic tissue/solid organ transplant.

Sites / Locations

  • Clermont Oncology Center ( Site 0018)Recruiting
  • Mid Florida Hematology and Oncology Center ( Site 0010)Recruiting
  • Orchard Healthcare Research Inc. ( Site 0011)Recruiting
  • Franciscan Health Lafayette East ( Site 0020)Recruiting
  • Mercy Health-Paducah Medical Oncology and Hematology ( Site 0006)Recruiting
  • Hattiesburg Clinic Hematology/Oncology ( Site 0008)Recruiting
  • Central Care Cancer Center - Bolivar ( Site 0017)Recruiting
  • Instituto Alexander Fleming ( Site 1008)Recruiting
  • Instituto de Investigaciones Clínicas Mar del Plata ( Site 1001)Recruiting
  • Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 1005)Recruiting
  • Sanatorio Parque ( Site 1003)Recruiting
  • Instituto Argentino de Diagnóstico y Tratamiento (IADT) ( Site 1002)Recruiting
  • Clinica Adventista Belgrano-Oncology ( Site 1004)Recruiting
  • Hospital Italiano de Córdoba ( Site 1000)Recruiting
  • CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA-Pesquisa Clínica ( Site 1102)Recruiting
  • Hospital de Câncer de Recife ( Site 1107)Recruiting
  • Instituto Joinvilense de Hematologia e Oncologia ( Site 1101)Recruiting
  • A. C. Camargo Cancer Center ( Site 1106)Recruiting
  • IC La Serena Research ( Site 1207)Recruiting
  • Oncocentro Valdivia ( Site 1201)Recruiting
  • FALP-UIDO ( Site 1203)Recruiting
  • Oncovida ( Site 1209)Recruiting
  • Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 1210)Recruiting
  • Instituto Nacional del Cancer-CR Investigación ( Site 1211)Recruiting
  • Bradfordhill-Clinical Area ( Site 1202)Recruiting
  • Anhui Provincial Hospital-Cancer Chemotherapy Department ( Site 4503)Recruiting
  • Beijing Cancer hospital-intrathoratic deparmtment II ( Site 4510)Recruiting
  • Beijing Peking Union Medical College Hospital-pneumology department ( Site 4501)Recruiting
  • Beijing Chest Hospital,Capital Medical University ( Site 4511)Recruiting
  • Chongqing Three Gorges Central Hospital ( Site 4516)Recruiting
  • Fujian Provincial Cancer Hospital ( Site 4517)Recruiting
  • Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine (Recruiting
  • Jiangmen Center Hospital ( Site 4509)Recruiting
  • ShenZhen People's Hospital ( Site 4504)Recruiting
  • Wuhan Union Hospital Cancer Center-Cancer center ( Site 4502)Recruiting
  • The First Affiliated Hospital of Nanchang University-Respiratory Medicine Department ( Site 4515)Recruiting
  • The First Affiliated Hospital of Xi'an Jiaotong University ( Site 4520)Recruiting
  • Fudan University Shanghai Cancer Center-Oncology ( Site 4512)Recruiting
  • Shanxi Cancer Hospital ( Site 4521)Recruiting
  • Tianjin Chest Hospital ( Site 4518)Recruiting
  • The First Affiliated Hospital, Zhejiang University-Respiratory Department ( Site 4514)Recruiting
  • Taizhou Hospital of Zhejiang Province-Respiratory ( Site 4508)Recruiting
  • Centre Hospitalier de Cornouaille Quimper - Concarneau ( Site 2600)Recruiting
  • Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau ( Site 2602)Recruiting
  • Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 2603)Recruiting
  • Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 1404)Recruiting
  • MEDI-K CAYALA ( Site 1403)Recruiting
  • Centro Regional de Sub Especialidades Médicas SA ( Site 1401)Recruiting
  • Centro Medico Integral De Cancerología (CEMIC) ( Site 1400)Recruiting
  • Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 2102)Recruiting
  • Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 2103)Recruiting
  • Törökbálinti Tüdőgyógyintézet ( Site 2105)Recruiting
  • Országos Korányi Pulmonológiai Intézet-VI. Tüdöbelosztály és Bronchológia ( Site 2100)Recruiting
  • Fujita Health University ( Site 4406)Recruiting
  • Gunma Prefectural Cancer Center ( Site 4416)Recruiting
  • National Hospital Organization Hokkaido Cancer Center ( Site 4415)Recruiting
  • Kanagawa Cardiovascular and Respiratory Center ( Site 4404)Recruiting
  • Miyagi Cancer Center ( Site 4401)Recruiting
  • Sendai Kousei Hospital ( Site 4400)Recruiting
  • Kurashiki Central Hospital ( Site 4409)Recruiting
  • Kansai Medical University Hospital ( Site 4408)Recruiting
  • Osaka Medical and Pharmaceutical University Hospital ( Site 4414)Recruiting
  • Saitama Prefectural Cancer Center ( Site 4402)Recruiting
  • Shizuoka Cancer Center ( Site 4405)Recruiting
  • Tochigi Cancer Center ( Site 4417)Recruiting
  • Juntendo University Hospital ( Site 4413)Recruiting
  • National Hospital Organization Kyushu Medical Center ( Site 4411)Recruiting
  • National Hospital Organization Kyushu Cancer Center ( Site 4410)Recruiting
  • Osaka International Cancer Institute ( Site 4407)Recruiting
  • Nippon Medical School Hospital ( Site 4403)Recruiting
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki PierRecruiting
  • Warmińsko - Mazurskie Centrum Chorób Płuc w Olsztynie-Oddzial Onkologii z Pododdzialem ChemioterapiiRecruiting
  • Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 2801)Recruiting
  • SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 2303)Recruiting
  • Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 2301)Recruiting
  • Cabinet Medical Oncomed ( Site 2305)Recruiting
  • Institutul Oncologic-Oncologie Medicala ( Site 2302)Recruiting
  • CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 2903)Recruiting
  • Medical Oncology Centre of Rosebank ( Site 2907)Recruiting
  • Steve Biko Academic Hospital-Medical Oncology ( Site 2904)Recruiting
  • Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 2900)Recruiting
  • The Oncology Centre ( Site 2901)Recruiting
  • Cape Town Oncology Trials ( Site 2902)Recruiting
  • CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 2404)Recruiting
  • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 2401)Recruiting
  • Hospital Universitari Vall d'Hebron-Oncology ( Site 2400)Recruiting
  • Hospital Universitario Juan Ramon Jimenez-Oncología Medica ( Site 2402)Recruiting
  • Changhua Christian Hospital ( Site 4203)Recruiting
  • Chang Gung Memorial Hospital at Kaohsiung ( Site 4200)Recruiting
  • National Taiwan University Cancer Center (NTUCC) ( Site 4205)Recruiting
  • Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 4207)Recruiting
  • E-Da hospital ( Site 4208)Recruiting
  • National Cheng Kung University Hospital ( Site 4202)Recruiting
  • National Taiwan University Hospital-Oncology ( Site 4204)Recruiting
  • Maharaj Nakorn Chiang Mai Hospital ( Site 4300)Recruiting
  • Chulalongkorn University ( Site 4301)Recruiting
  • Division of Medical Oncology, Siriraj H ( Site 4303)Recruiting
  • I.E.U. Medical Point Hastanesi-Oncology ( Site 2507)Recruiting
  • Gulhane Egitim Arastirma Hastanesi-Oncology ( Site 2504)Recruiting
  • Hacettepe Universite Hastaneleri-oncology hospital ( Site 2506)Recruiting
  • Ankara City Hospital-Medical Oncology ( Site 2501)Recruiting
  • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2502)Recruiting
  • Memorial Kayseri Hastanesi ( Site 2500)Recruiting
  • İnönü Üniversitesi Turgut Özal Tıp Merkezi-medical oncology depertmant ( Site 2503)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1 (MK-3475A + Platinum Doublet Chemotherapy)

Arm 2 (Pembrolizumab + Platinum Doublet Chemotherapy)

Arm Description

Participants with treatment-naïve metastatic NSCLC will receive MK 3475A SC in combination with platinum doublet chemotherapy.

Participants with treatment-naïve metastatic NSCLC will receive Pembrolizumab IV in combination with platinum doublet chemotherapy.

Outcomes

Primary Outcome Measures

Area Under the Curve (AUC) of Pembrolizumab Measured After the First Dose
AUC is defined as area under curve exposure. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine AUC.
Trough Concentration (Ctrough) of Pembrolizumab Measured at Steady State
Ctrough is defined as the trough concentration at steady-state. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Ctrough.

Secondary Outcome Measures

Maximum Serum Concentration (Cmax) of Pembrolizumab Measured After the First Dose
Cmax is defined as the peak concentration over the dosing interval. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Cmax.
Trough Concentration (Ctrough) of Pembrolizumab Measured After the First Dose
Ctrough is defined as the trough concentration. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Ctrough.
Area Under the Curve (AUC) of Pembrolizumab Measured at Steady State
AUC is defined as area under curve exposure at steady state. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine AUC.
Maximum Serum Concentration (Cmax) of Pembrolizumab Measured at Steady State
Cmax is defined as the peak concentration over the dosing interval in steady-state. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Cmax
Number of Participants Who Test Positive for Anti-Drug Antibodies (ADAs) for Pembrolizumab
Blood samples are to be collected at designated time points for the determination of the presence or absence of anti-pembrolizumab antibodies. The percentage of participants who develop anti pembrolizumab antibodies will be reported.
Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)
The ORR is defined as the percentage of participants who achieve a confirmed CR or PR per RECIST 1.1 as assessed by BICR.
Progression-free Survival (PFS) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 by BICR or death due to any cause, whichever occurs first.
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Duration of Response (DOR) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)
For participants who show confirmed CR or PR, DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
Number of Participants Who Experienced at Least One Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with an AE will be reported for Arms 1 and 2.
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported for Arms 1 and 2.
Change From Baseline in the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) Score-Items 29 and 30
EORTC QLQ-C30 is a psychometrically and clinically validated instrument appropriate for assessing HRQoL in oncology studies. The EORTC QLQ-C30 is the most widely used cancer-specific HRQoL instrument, which contains 30 items and measures 5 functional dimensions (physical, role, emotional, cognitive and social), 3 symptom items (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial impact), and a global health and QoL scale. For the global health status or QoL and function scales, a higher value indicates a better level of function; for symptom scales and items, a higher value indicates increased severity of symptoms.
Change From Baseline in the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30) Physical Functioning Score-Items 1 to 5
The EQ-5D-5L is a standardized instrument for use as a measure of health outcome and will provide data to develop health utilities for use in health economic analyses. The 5 health state dimensions in the EQ-5D-5L include the following: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension is rated on a 5-point scale from 1 (no problem) to 5 (unable to/extreme problems). The EQ-5D-5L also includes a graded (0 to 100) vertical visual analog scale on which the participant rates his or her general state of health at the time of the assessment. This instrument has been used extensively in cancer studies and published results from these studies support its validity and reliability.
Change From Baseline in the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30) Role Functioning Score-Items 6 and 7
The EQ-5D-5L is a standardized instrument for use as a measure of health outcome and will provide data to develop health utilities for use in health economic analyses. The 5 health state dimensions in the EQ-5D-5L include the following: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension is rated on a 5-point scale from 1 (no problem) to 5 (unable to/extreme problems). The EQ-5D-5L also includes a graded (0 to 100) vertical visual analog scale on which the participant rates his or her general state of health at the time of the assessment. This instrument has been used extensively in cancer studies and published results from these studies support its validity and reliability.

Full Information

First Posted
January 27, 2023
Last Updated
October 18, 2023
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05722015
Brief Title
A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77)
Official Title
A Phase 3 Randomized, Open-label Clinical Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) Versus Intravenous Pembrolizumab, Administered With Chemotherapy, in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 14, 2023 (Actual)
Primary Completion Date
September 23, 2024 (Anticipated)
Study Completion Date
May 22, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is to assess the pharmacokinetics (PK) and safety of SC MK-3475A vs intravenous (IV) pembrolizumab, administered with chemotherapy in first line treatment of adult participants with metastatic non-small cell lung cancer. The primary hypotheses of this study are MK-3475A subcutaneous (SC) is noninferior to pembrolizumab IV with respect to PK parameters.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
339 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 (MK-3475A + Platinum Doublet Chemotherapy)
Arm Type
Experimental
Arm Description
Participants with treatment-naïve metastatic NSCLC will receive MK 3475A SC in combination with platinum doublet chemotherapy.
Arm Title
Arm 2 (Pembrolizumab + Platinum Doublet Chemotherapy)
Arm Type
Active Comparator
Arm Description
Participants with treatment-naïve metastatic NSCLC will receive Pembrolizumab IV in combination with platinum doublet chemotherapy.
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab coformulated with hyaluronidase
Other Intervention Name(s)
MK-3475A
Intervention Description
MK3475A SC will be administered for squamous and nonsquamous NSCLC as per the schedule specified in arm; participants may be eligible for second course.
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Other Intervention Name(s)
Alimta
Intervention Description
Pemetrexed 500 mg/m² by IV Infusion will be administered for nonsquamous NSCLC as per the schedule specified in arm.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
Platinol-AQ
Intervention Description
Cisplatin 75 mg/m² by IV Infusion will be administered for nonsquamous and squamous NSCLC as per the schedule specified in arm.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin AUC 5 mg/mL/min in nonsquamous and AUC 6 mg/mL/min in squamous NSCLC will be administered as per the schedule specified in arm.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Taxol
Intervention Description
Paclitaxel 200 mg/m² by IV Infusion will be administered for squamous NSCLC as per the schedule specified in arm.
Intervention Type
Drug
Intervention Name(s)
Nab-paclitaxel
Other Intervention Name(s)
Albumin-bound paclitaxel
Intervention Description
Nab-paclitaxel 100 mg/m² by IV Infusion will be administered for squamous NSCLC as per the schedule specified in arm.
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
MK-3475, KEYTRUDA
Intervention Description
Pembrolizumab by IV Infusion will be administered for squamous and nonsquamous NSCLC as per the schedule specified in arm; participants may be eligible for second course.
Primary Outcome Measure Information:
Title
Area Under the Curve (AUC) of Pembrolizumab Measured After the First Dose
Description
AUC is defined as area under curve exposure. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine AUC.
Time Frame
At designated time points (Up to ~14 months).
Title
Trough Concentration (Ctrough) of Pembrolizumab Measured at Steady State
Description
Ctrough is defined as the trough concentration at steady-state. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Ctrough.
Time Frame
At designated time points (Up to ~18 months)
Secondary Outcome Measure Information:
Title
Maximum Serum Concentration (Cmax) of Pembrolizumab Measured After the First Dose
Description
Cmax is defined as the peak concentration over the dosing interval. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Cmax.
Time Frame
At designated time points (Up to ~28 months)
Title
Trough Concentration (Ctrough) of Pembrolizumab Measured After the First Dose
Description
Ctrough is defined as the trough concentration. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Ctrough.
Time Frame
At designated time points (Up to ~28 months)
Title
Area Under the Curve (AUC) of Pembrolizumab Measured at Steady State
Description
AUC is defined as area under curve exposure at steady state. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine AUC.
Time Frame
At designated time points (Up to ~28 months)
Title
Maximum Serum Concentration (Cmax) of Pembrolizumab Measured at Steady State
Description
Cmax is defined as the peak concentration over the dosing interval in steady-state. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Cmax
Time Frame
At designated time points (Up to ~28 months)
Title
Number of Participants Who Test Positive for Anti-Drug Antibodies (ADAs) for Pembrolizumab
Description
Blood samples are to be collected at designated time points for the determination of the presence or absence of anti-pembrolizumab antibodies. The percentage of participants who develop anti pembrolizumab antibodies will be reported.
Time Frame
At designated time points (Up to ~28 months)
Title
Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)
Description
The ORR is defined as the percentage of participants who achieve a confirmed CR or PR per RECIST 1.1 as assessed by BICR.
Time Frame
Up to~60 months
Title
Progression-free Survival (PFS) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)
Description
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 by BICR or death due to any cause, whichever occurs first.
Time Frame
Up to~60 months
Title
Overall Survival (OS)
Description
OS is defined as the time from randomization to death due to any cause.
Time Frame
Up to~60 months
Title
Duration of Response (DOR) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)
Description
For participants who show confirmed CR or PR, DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
Time Frame
Up to~60 months
Title
Number of Participants Who Experienced at Least One Adverse Event (AE)
Description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with an AE will be reported for Arms 1 and 2.
Time Frame
Up to~28 months
Title
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
Description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported for Arms 1 and 2.
Time Frame
Up to~25 months
Title
Change From Baseline in the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) Score-Items 29 and 30
Description
EORTC QLQ-C30 is a psychometrically and clinically validated instrument appropriate for assessing HRQoL in oncology studies. The EORTC QLQ-C30 is the most widely used cancer-specific HRQoL instrument, which contains 30 items and measures 5 functional dimensions (physical, role, emotional, cognitive and social), 3 symptom items (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial impact), and a global health and QoL scale. For the global health status or QoL and function scales, a higher value indicates a better level of function; for symptom scales and items, a higher value indicates increased severity of symptoms.
Time Frame
Baseline and up to ~28 months
Title
Change From Baseline in the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30) Physical Functioning Score-Items 1 to 5
Description
The EQ-5D-5L is a standardized instrument for use as a measure of health outcome and will provide data to develop health utilities for use in health economic analyses. The 5 health state dimensions in the EQ-5D-5L include the following: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension is rated on a 5-point scale from 1 (no problem) to 5 (unable to/extreme problems). The EQ-5D-5L also includes a graded (0 to 100) vertical visual analog scale on which the participant rates his or her general state of health at the time of the assessment. This instrument has been used extensively in cancer studies and published results from these studies support its validity and reliability.
Time Frame
Baseline and up to ~28 months
Title
Change From Baseline in the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30) Role Functioning Score-Items 6 and 7
Description
The EQ-5D-5L is a standardized instrument for use as a measure of health outcome and will provide data to develop health utilities for use in health economic analyses. The 5 health state dimensions in the EQ-5D-5L include the following: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension is rated on a 5-point scale from 1 (no problem) to 5 (unable to/extreme problems). The EQ-5D-5L also includes a graded (0 to 100) vertical visual analog scale on which the participant rates his or her general state of health at the time of the assessment. This instrument has been used extensively in cancer studies and published results from these studies support its validity and reliability.
Time Frame
Baseline and up to ~28 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
The key inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: Has histologically or cytologically confirmed diagnosis of squamous or non-squamous Non-small Cell Lung Cancer (NSCLC). Must provide archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated. Has a life expectancy of at least 3 months. Exclusion Criteria: Has a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements. Has received prior systemic anticancer therapy for metastatic NSCLC. Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization. Has received prior radiotherapy within 2 weeks of start of study intervention or has radiation-related toxicity requiring corticosteroids. Has received radiation therapy to the lung (>30 Gray) within 6 months of start of study intervention. Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Has an active autoimmune disease that has required systemic treatment in past 2 years. Has an active infection requiring systemic therapy. Has a history of human immunodeficiency virus (HIV) infection. Has a history of Hepatitis B or C. Has not adequately recovered from major surgery or has ongoing surgical complications. Has a history of allogenic tissue/solid organ transplant.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Toll Free Number
Phone
1-888-577-8839
Email
Trialsites@merck.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Clermont Oncology Center ( Site 0018)
City
Clermont
State/Province
Florida
ZIP/Postal Code
34711
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
352-242-1366
Facility Name
Mid Florida Hematology and Oncology Center ( Site 0010)
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
407-353-1915
Facility Name
Orchard Healthcare Research Inc. ( Site 0011)
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
224-534-7580
Facility Name
Franciscan Health Lafayette East ( Site 0020)
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
47905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
765-502-4016
Facility Name
Mercy Health-Paducah Medical Oncology and Hematology ( Site 0006)
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
248-632-0743
Facility Name
Hattiesburg Clinic Hematology/Oncology ( Site 0008)
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
601-261-1700
Facility Name
Central Care Cancer Center - Bolivar ( Site 0017)
City
Bolivar
State/Province
Missouri
ZIP/Postal Code
65613
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
417-326-7200
Facility Name
Instituto Alexander Fleming ( Site 1008)
City
Ciudad Autónoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1426ANZ
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
5491166936669
Facility Name
Instituto de Investigaciones Clínicas Mar del Plata ( Site 1001)
City
Mar del Plata
State/Province
Buenos Aires
ZIP/Postal Code
B7600FZO
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+5492235937663
Facility Name
Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 1005)
City
ABB
State/Province
Caba
ZIP/Postal Code
C1199ABB
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
541149590200 8159
Facility Name
Sanatorio Parque ( Site 1003)
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000DSV
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
5493416955611
Facility Name
Instituto Argentino de Diagnóstico y Tratamiento (IADT) ( Site 1002)
City
Buenos Aires
ZIP/Postal Code
C1122AAL
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
(+54 911) 4162-5353
Facility Name
Clinica Adventista Belgrano-Oncology ( Site 1004)
City
Caba
ZIP/Postal Code
C1430EGF
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
5491132682903
Facility Name
Hospital Italiano de Córdoba ( Site 1000)
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
5493515446813
Facility Name
CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA-Pesquisa Clínica ( Site 1102)
City
Fortaleza
State/Province
Ceara
ZIP/Postal Code
60336-232
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+5585991372979
Facility Name
Hospital de Câncer de Recife ( Site 1107)
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50040-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
5581987473222
Facility Name
Instituto Joinvilense de Hematologia e Oncologia ( Site 1101)
City
Joinville
State/Province
Santa Catarina
ZIP/Postal Code
89201260
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
554734331849
Facility Name
A. C. Camargo Cancer Center ( Site 1106)
City
Sao Paulo
ZIP/Postal Code
01509-010
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+5511993607754
Facility Name
IC La Serena Research ( Site 1207)
City
La Serena
State/Province
Coquimbo
ZIP/Postal Code
1720430
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
56953360057
Facility Name
Oncocentro Valdivia ( Site 1201)
City
Valdivia
State/Province
Los Rios
ZIP/Postal Code
5112129
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+56992195434
Facility Name
FALP-UIDO ( Site 1203)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7500921
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
56224457254
Facility Name
Oncovida ( Site 1209)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7510032
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
5624205100
Facility Name
Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 1210)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8330032
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+56963413803
Facility Name
Instituto Nacional del Cancer-CR Investigación ( Site 1211)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8380455
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
56994305996
Facility Name
Bradfordhill-Clinical Area ( Site 1202)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8420383
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+56998744662
Facility Name
Anhui Provincial Hospital-Cancer Chemotherapy Department ( Site 4503)
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230071
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
8613805695536
Facility Name
Beijing Cancer hospital-intrathoratic deparmtment II ( Site 4510)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
861088196479
Facility Name
Beijing Peking Union Medical College Hospital-pneumology department ( Site 4501)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13911235467
Facility Name
Beijing Chest Hospital,Capital Medical University ( Site 4511)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
101149
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
8613681445657
Facility Name
Chongqing Three Gorges Central Hospital ( Site 4516)
City
Wanzhou
State/Province
Chongqing
ZIP/Postal Code
404199
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
8613896327099
Facility Name
Fujian Provincial Cancer Hospital ( Site 4517)
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+86 0591-83660063
Facility Name
Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine (
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+86 020 61641888
Facility Name
Jiangmen Center Hospital ( Site 4509)
City
Jiangmen
State/Province
Guangdong
ZIP/Postal Code
529030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+86 0750-3165555
Facility Name
ShenZhen People's Hospital ( Site 4504)
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+86 0755 25533018
Facility Name
Wuhan Union Hospital Cancer Center-Cancer center ( Site 4502)
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13986252286
Facility Name
The First Affiliated Hospital of Nanchang University-Respiratory Medicine Department ( Site 4515)
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0791-88695125
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University ( Site 4520)
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
8613572824106
Facility Name
Fudan University Shanghai Cancer Center-Oncology ( Site 4512)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
8613501623469
Facility Name
Shanxi Cancer Hospital ( Site 4521)
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13643518252
Facility Name
Tianjin Chest Hospital ( Site 4518)
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300051
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
18522671578
Facility Name
The First Affiliated Hospital, Zhejiang University-Respiratory Department ( Site 4514)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0571-87236595
Facility Name
Taizhou Hospital of Zhejiang Province-Respiratory ( Site 4508)
City
Taizhou
State/Province
Zhejiang
ZIP/Postal Code
317000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13867622009
Facility Name
Centre Hospitalier de Cornouaille Quimper - Concarneau ( Site 2600)
City
Quimper
State/Province
Finistere
ZIP/Postal Code
29107
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
33899282481
Facility Name
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau ( Site 2602)
City
Tours
State/Province
Indre-et-Loire
ZIP/Postal Code
37032
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
33247474747
Facility Name
Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 2603)
City
Paris
ZIP/Postal Code
75679
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
33158413091
Facility Name
Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 1404)
City
Ciudad de Guatemala
ZIP/Postal Code
01010
Country
Guatemala
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
50230635474
Facility Name
MEDI-K CAYALA ( Site 1403)
City
Guatemala
ZIP/Postal Code
01016
Country
Guatemala
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
50249340261
Facility Name
Centro Regional de Sub Especialidades Médicas SA ( Site 1401)
City
Quetzaltenango
ZIP/Postal Code
09001
Country
Guatemala
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+50259450559
Facility Name
Centro Medico Integral De Cancerología (CEMIC) ( Site 1400)
City
Quetzaltenango
ZIP/Postal Code
09002
Country
Guatemala
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
50259458053
Facility Name
Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 2102)
City
Kecskemét
State/Province
Bacs-Kiskun
ZIP/Postal Code
6000
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3676516719
Facility Name
Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 2103)
City
Szolnok
State/Province
Jasz-Nagykun-Szolnok
ZIP/Postal Code
5004
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
36209323256
Facility Name
Törökbálinti Tüdőgyógyintézet ( Site 2105)
City
Törökbálint
State/Province
Pest
ZIP/Postal Code
2045
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
36307005601
Facility Name
Országos Korányi Pulmonológiai Intézet-VI. Tüdöbelosztály és Bronchológia ( Site 2100)
City
Budapest
ZIP/Postal Code
1121
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
36 30 200 5233
Facility Name
Fujita Health University ( Site 4406)
City
Toyoake
State/Province
Aichi
ZIP/Postal Code
470-1192
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
81562932139
Facility Name
Gunma Prefectural Cancer Center ( Site 4416)
City
Otashi
State/Province
Gunma
ZIP/Postal Code
373-8550
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
81276380771
Facility Name
National Hospital Organization Hokkaido Cancer Center ( Site 4415)
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
003-0804
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81118119111
Facility Name
Kanagawa Cardiovascular and Respiratory Center ( Site 4404)
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
236-0051
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0457019581
Facility Name
Miyagi Cancer Center ( Site 4401)
City
Natori
State/Province
Miyagi
ZIP/Postal Code
981-1293
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
81223843151
Facility Name
Sendai Kousei Hospital ( Site 4400)
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
9800873
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
81222226181
Facility Name
Kurashiki Central Hospital ( Site 4409)
City
Kurashiki
State/Province
Okayama
ZIP/Postal Code
710-8602
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81864220210
Facility Name
Kansai Medical University Hospital ( Site 4408)
City
Hirakata
State/Province
Osaka
ZIP/Postal Code
5731191
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
819031784122
Facility Name
Osaka Medical and Pharmaceutical University Hospital ( Site 4414)
City
Takatsuki
State/Province
Osaka
ZIP/Postal Code
569-8686
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81726831221
Facility Name
Saitama Prefectural Cancer Center ( Site 4402)
City
Ina-machi
State/Province
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0487221111
Facility Name
Shizuoka Cancer Center ( Site 4405)
City
Nagaizumi-cho,Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
81559895222
Facility Name
Tochigi Cancer Center ( Site 4417)
City
Utsunomiya
State/Province
Tochigi
ZIP/Postal Code
320-0834
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-28-658-5151
Facility Name
Juntendo University Hospital ( Site 4413)
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+819086747990
Facility Name
National Hospital Organization Kyushu Medical Center ( Site 4411)
City
Fukuoka
ZIP/Postal Code
810-8563
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
81928520700
Facility Name
National Hospital Organization Kyushu Cancer Center ( Site 4410)
City
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
81925413231
Facility Name
Osaka International Cancer Institute ( Site 4407)
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
81669451181
Facility Name
Nippon Medical School Hospital ( Site 4403)
City
Tokyo
ZIP/Postal Code
113-8603
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
81338222131
Facility Name
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-781
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
48225463066
Facility Name
Warmińsko - Mazurskie Centrum Chorób Płuc w Olsztynie-Oddzial Onkologii z Pododdzialem Chemioterapii
City
Olsztyn
State/Province
Warminsko-mazurskie
ZIP/Postal Code
10-357
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48791789626
Facility Name
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 2801)
City
Koszalin
State/Province
Zachodniopomorskie
ZIP/Postal Code
75-581
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
48502204953
Facility Name
SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 2303)
City
Florești
State/Province
Cluj
ZIP/Postal Code
407280
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
40742206212
Facility Name
Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 2301)
City
Craiova
State/Province
Dolj
ZIP/Postal Code
200542
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
40722161545
Facility Name
Cabinet Medical Oncomed ( Site 2305)
City
Timișoara
State/Province
Timis
ZIP/Postal Code
300239
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
40744571617
Facility Name
Institutul Oncologic-Oncologie Medicala ( Site 2302)
City
Cluj
ZIP/Postal Code
400015
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
40745646368
Facility Name
CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 2903)
City
Port Elizabeth
State/Province
Eastern Cape
ZIP/Postal Code
6055
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
27413630581
Facility Name
Medical Oncology Centre of Rosebank ( Site 2907)
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2196
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+27118804222
Facility Name
Steve Biko Academic Hospital-Medical Oncology ( Site 2904)
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0001
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
27123541054
Facility Name
Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 2900)
City
Sandton
State/Province
Gauteng
ZIP/Postal Code
2196
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
27118830900
Facility Name
The Oncology Centre ( Site 2901)
City
Durban
State/Province
Kwazulu-Natal
ZIP/Postal Code
4091
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
27312099030
Facility Name
Cape Town Oncology Trials ( Site 2902)
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7570
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
27219443832
Facility Name
CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 2404)
City
Santiago de Compostela
State/Province
La Coruna
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
34981950511
Facility Name
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 2401)
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34914269393
Facility Name
Hospital Universitari Vall d'Hebron-Oncology ( Site 2400)
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34932746085
Facility Name
Hospital Universitario Juan Ramon Jimenez-Oncología Medica ( Site 2402)
City
Huelva
ZIP/Postal Code
21005
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
34959016737
Facility Name
Changhua Christian Hospital ( Site 4203)
City
Changhua County
State/Province
Changhua
ZIP/Postal Code
50006
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
886472385957791
Facility Name
Chang Gung Memorial Hospital at Kaohsiung ( Site 4200)
City
Kaohsiung Niao Sung Dist
State/Province
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
88677317123
Facility Name
National Taiwan University Cancer Center (NTUCC) ( Site 4205)
City
Taipei City
State/Province
Taipei
ZIP/Postal Code
106
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
88622312345667511
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 4207)
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
886-7-3121101 ext5651
Facility Name
E-Da hospital ( Site 4208)
City
Kaohsiung
ZIP/Postal Code
82445
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+88676150011 ext. 5056
Facility Name
National Cheng Kung University Hospital ( Site 4202)
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
National Taiwan University Hospital-Oncology ( Site 4204)
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
88622312345667511
Facility Name
Maharaj Nakorn Chiang Mai Hospital ( Site 4300)
City
Muang
State/Province
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
6653935480
Facility Name
Chulalongkorn University ( Site 4301)
City
Bangkok
State/Province
Krung Thep Maha Nakhon
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
66818178198
Facility Name
Division of Medical Oncology, Siriraj H ( Site 4303)
City
Siriraj
State/Province
Krung Thep Maha Nakhon
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
6624194488
Facility Name
I.E.U. Medical Point Hastanesi-Oncology ( Site 2507)
City
Izmir, Karsiyaka
State/Province
Izmir
ZIP/Postal Code
009035575
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905052642353
Facility Name
Gulhane Egitim Arastirma Hastanesi-Oncology ( Site 2504)
City
Ankara
ZIP/Postal Code
06010
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
905366401020
Facility Name
Hacettepe Universite Hastaneleri-oncology hospital ( Site 2506)
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905334318506
Facility Name
Ankara City Hospital-Medical Oncology ( Site 2501)
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
905555306271
Facility Name
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2502)
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
00905063509061
Facility Name
Memorial Kayseri Hastanesi ( Site 2500)
City
Kayseri
ZIP/Postal Code
38010
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
905530494238
Facility Name
İnönü Üniversitesi Turgut Özal Tıp Merkezi-medical oncology depertmant ( Site 2503)
City
Malatya
ZIP/Postal Code
44280
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
905385003562

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Links:
URL
https://www.merckclinicaltrials.com/
Description
Merck Clinical Trials Information
URL
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=3475A-D77&&kw=3475A-D77
Description
Plain Language Summary

Learn more about this trial

A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77)

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